Kornimate/medical-research-clean huggingface dataset:
a study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients with unstable angina not responding to standard medical therapy who are eligible for coronary angioplasty

Conditions: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary

Summary: the purpose of this study is to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, versus placebo in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty.

this is a randomized, placebo-controlled study to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty. the primary outcomes of the study include any of the following within 30 days: the number of deaths from any cause, myocardial infarctions or the number of recurrent ischemic events requiring urgent intervention (such as a coronary artery bypass surgery, repeat coronary angioplasty, coronary stent placement, or intra-aortic balloon pump). please see attached results. patients will be treated with abciximab or matching placebo.

Eligibility criteria:
inclusion criteria: * patients with refractory angina as evidenced by at least one episode of ischemia (chest pain and/or st-t changes) despite bed rest and at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin, or persistent newly developed negative t-waves occurring or continuing after at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin * having clinical signs and symptoms of angina at rest or minimal exertion with dynamic st-segment and/or t-wave changes * having an episode of chest pain within 48 hours prior to the start of study agent administration * having a culprit lesion in a single native coronary vessel suitable for angioplasty on the qualifying angiogram exclusion criteria: * patients who have had a recent myocardial infarction, unless ck has returned to less than twice the upper limit of normal * having features of ongoing ischemia that would require immediate intervention, or had a percutaneous transluminal coronary angioplasty (ptca) within the past 24 hours * having an unprotected occlusion of the main left coronary artery \> 50%, a culprit lesion located in a venous or arterial bypass graft, or recent bleeding or a condition associated with increased bleeding risk * receiving concurrent administration of oral anticoagulants at the time of study entry, administration of intravenous dextran (prior to or planned for use during angioplasty), or planned administration of thrombolytic agent prior to or during angioplasty * having persistent hypertension at admission despite treatment, or a platelet count less than 100,000 per millimeter cubed

Keywords: angina, unstable angioplasty, transluminal, percutaneous coronary abciximab
a phase ⅲ clinical study of hlx22 in combination with trastuzumab and chemotherapy for the treatment of gastroesophageal junction and gastric cancer

Conditions: Gastroesophageal-junction Cancer; Monoclonal Antibody; Gastric Cancer; HER2-positive Gastric Cancer

Summary: this is a double-blind, randomized, multiregion, comparative phase ⅲ clinical study designed to evaluate the efficacy and safety of hlx22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with her2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (g/gej).eligible subjects will be randomized to the two groups based on a 1:1 ratio. enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

in experimental group: hlx22 (15 mg/kg) + trastuzumab + chemotherapy (xelox) ± placebo (for pembrolizumab), once every 3 weeks (q3w). in control group: placebo (for hlx22) + trastuzumab + chemotherapy (xelox) ± pembrolizumab, q3w.

Eligibility criteria:
inclusion criteria: 1. male/female who are at least 18 years of age on the day of signing the informed consent. 2. with histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic her2-positive gastric or gastroesophageal junction adenocarcinoma. 3. had measurable disease as assessed by irrc according to the recist v1.1, the target lesion must not be a bone metastatic lesion only. 4. her2-positive tumor defined as either ihc 3+ or ihc 2+ in combination with ish+ or fish, as assessed by a central laboratory on a primary or metastatic tumor. 5. ecog ps within 7 days before randomization: 0-1. 6. expected survival ≥ 6 months. 7. had adequate organ function exclusion criteria: 1. patients with other malignant tumors within 2 years before the randomization. 2. evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. 3. previous treatment with any her2-target therapy. 4. active gastrointestinal bleeding 5. presence of central nervous system (cns) metastases. 6. left ventricular ejection fraction (lvef) \< 55%. 7. subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
the effect of single task vs. dual task assessment in individuals with knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular osteophytes.

dual tasking is when two tasks can be done simultaneously. a dual task may involve two different simultaneous motor tasks, or it may include a cognitive task in addition to the motor task. following the additional task given, there may be a decrease in the performance of the main task or in the performance of both tasks. decreased balance control can lead to fall injuries that result in serious physical, psychological and social losses. before the management of this condition, an effective evaluation of balance control in patients with knee osteoarthritis is required.

Eligibility criteria:
inclusion criteria: * being between the ages of 40-65 * a diagnosis of knee osteoarthritis in at least one of the knees clinically and radiographically according to the criteria of the american society of rheumatology * findings consistent with stage ii-iii osteoarthritis * pain is between 2 and 7 according to the visual analog scale. exclusion criteria: * acute osteoarthritis in the knee * comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries for which exercise is contraindicated * nsaid and similar disease-modifying drug use (diaserein, glucosamine, etc.) * having exercised regularly in the last 6 months (more than 1 day per week) * having undergone arthroplasty surgery * intra-articular injection (hyaluronic acid/steroid) administration in the last 6 months

Keywords: dual task
high dose daunorubicin vs. standard dose daunorubicin in induction treatment of aml

Conditions: ACUTE MYELOGENOUS LEUKEMIA

Summary: determine the effects of escalated dose of daunorubicin in induction treatment of adult patients with acute myelogenous leukemia who are younger than 60 years of age.

1. induction chemotherapy * for patients randomized to receive regular dose of daunorubicin (arm i) will be given cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days along with daunorubicin 45 mg/m2/day by continuous iv infusion over 24 hours daily for 3 days. * for patients randomized to receive higher dose of daunorubicin (arm ii) will be given cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days along with daunorubicin 90 mg/m2/day by continuous iv infusion over 24 hours daily for 3 days. 2. reinduction chemotherapy * bone marrow aspiration and biopsy will be performed on day 14 of induction chemotherapy. if the bone marrow is hypoplastic and contains no more than 5% blast cells, further chemotherapy will be deferred and the marrow examination will be repeated at the time of anc ≥ 1,500/μl and platelets ≥ 100,000/μl in the peripheral blood for the evaluation of complete remission. if more than 5% blast cells persist or if the marrow cellularity in the biopsy specimen exceeds 15%, a course of reinduction chemotherapy will be given. * reinduction chemotherapy consists of cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 5 days along with daunorubicin 45 mg/m2/day by continuous iv infusion over 24 hours daily for 2 days in both arms. 3. postremission therapy * the same postremission therapy will be given to the patients in both arms. * four courses of cytarabine 3 g/m2 will be administered in a 3-hour iv infusion every 12 hours (twice daily) on days 1, 3, and 5 for a total of six doses per course. after the four courses of cytarabine therapy, patients will receive two monthly treatments with cytarabine (200 mg/m2/day by a 3-hour iv infusion for 5 days) and daunorubicin (45 mg/m2 by rapid iv infusion on the first treatment day). * if patients have hla-matched sibling or unrelated donors, allogeneic stem cell transplantation will be performed. * a complete remission will be defined as ≤ 5% blasts in a normocellular bone marrow with anc ≥ 1,500/μl and platelets ≥ 100,000/μl in the peripheral blood and the disappearance of all blasts in bone marrow.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed aml or raeb * 15 years of age or older, but younger than 60 years of age * adequate hepatic and renal function * normal cardiac function with lvef ≥ 50% on muga scan or echocardiogram * written informed consent exclusion criteria: * promyelocytic leukemia or chronic myelogenous leukemia * significant infection * prior chemotherapy history for leukemia
to compare the efficacy and safety of layla in osteoarthritis patients of the knee

Conditions: Osteoarthritis of the Knee

Summary: this is a randomized, double-blind study to compare the efficacy and safety of layla tablet and cenatone tablet in the treatment of osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * patients ≥40 and ≤80 years of age * radiographic evidence of grade 1,2 or 3 osteoarthritis based on the kellgren \& lawrence radiographic entry criteria * stable osteoarthritis during 3 months * score of 100mm pain vas ≤ 80mm at screening * score of 100mm pain vas ≥ 40mm at baseline * written consent form voluntarily exclusion criteria: * disease of spine or other lower limb joints that could affect fo evaluate the efficacy * history of surgery or arthroscopy of the study joint within 6 months * trauma of study joint within 12 months * medication of constantly(more than 1 week) corticosteroid by oral within 3 months * diagnosed with psychical disorder, and taking medication * medication of intra-articular injection within 3 months * uncontrollable hypertension patients at screening test * history of upper gastrointestinal ulceration within 6 months, history of upper gastrointestinal bleeding within 12 months * history of lower gastrointestinal bleeding within 12 months * history of coronary artery bypass, systemic lupus erythematosus or mixed connective tissue disease * serum creatinine, alt, ast, total bilirubin over uln x 2.0 at screening test * history of hypersensitivity of layla, cenatone or nsaids * participation in another clinical trials within 4 weeks * medication of constantly (more than 1 week) narcotic analgesics within 3 months * not consent about using effectual contraception method during trial * pregnant or lactating woman * history of malignant tumor within 5 years * investigator's judgment

Keywords: layla non-inferiority 100mm pain vas
a clinical trial to evaluate the pharmacokinetics and tolerability of ckd-348

Conditions: Hypertension and Dyslipidemia

Summary: a clinical trial to evaluate the pharmacokinetics and tolerability of ckd-348

a phase 1 clinical trial to evaluate the tolerability and pharmacokinetics in healthy adult volunteers after administration of ckd-348 and co-administration of ckd-828, d097, d337.

Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19 years 2. weight ≥50kg (man) or 45kg (woman), with calculated body mass index (bmi) of 18 to 30 kg/m2 3. those who meet the blood pressure criteria during screening tests: a. systolic blood pressure: 90 to 139 mmhg b. diastolic blood pressure: 60 to 89 mmhg 4. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 5. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ecg results at screening. 6. those who agree to contraception during the participation of clinical trial 7. individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial. exclusion criteria: 1. those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 2. those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products. 3. those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month. 4. those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 5. those who exceed an alcohol and cigarette consumption than below criteria a. alcohol: man- 21 glasses/week, woman - 14 glasses/week (1 glass: soju 50ml, wine 30ml, or beer 250ml) b. smoking: 20 cigarettes/day 6. those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism. 7. those who have genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption. 8. those who are deemed insufficient to participate in this clinical study by investigators. 9. woman who are pregnant or breastfeeding.

Keywords: ckd-348
pharmacokinetics of amlodipine besylate at delivery and during lactation

Conditions: Chronic Hypertension in Pregnancy

Summary: this is a phase iv prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. the study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.

we plan to evaluate the pharmacokinetics of amlodipine besylate at the time of delivery, to determine if transplacental passage of the drug occurs. we will also examine the drug kinetics in postpartum lactation to establish whether amlodipine is excreted into breast milk. the outcomes of interest are plasma concentration of amlodipine at delivery and the drug concentrations in blood and breast milk over a twenty-hour steady-state period following milk-supply establishment. fifteen patients already taking 5 mg of amlodipine during pregnancy for the treatment of chronic hypertension will be recruited from the antepartum obstetric complications clinic at parkland hospital. only women who are breastfeeding will be eligible for the study. patients who elect to participate in the study will continue their amlodipine 5 mg dosing through delivery and into the postpartum period. maternal blood will be drawn within one hour of delivery and fetal cord blood collected at the time of delivery. patients will then have blood drawn over a 24 hour period beginning on postpartum day 2 after delivery following administration of their once-daily amlodipine dose. at each blood draw, the patient will also use a breast pump to express breast milk for paired analysis. both blood and breast milk amlodipine levels will be calculated for all samples. the levels will be used to determine the pharmacokinetics of amlodipine in the peri- and postpartum patient, including concentrations in plasma and breast milk. in addition to collecting maternal data, a range of clinical information will be collected on each study patient's infant including weight, apgar scores, hemodynamic parameters, physical examination and hospital course. this information will be used to screen for any potential complications associated with infant exposure to amlodipine. an infant blood sample will also be obtained in conjunction with the routine neonatal blood collection that occurs at 1-2 days of postnatal life and this will be analyzed to determine serum amlodipine concentration in breastfeeding infants.

Eligibility criteria:
inclusion criteria: * 18 years or older; * pregnant female * already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy; * hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery * breastfeeding or breast and bottle-feeding their infant exclusion criteria: * known kidney disease * delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage * administration of greater than 5 mg of amlodipine in 24 hour period

Keywords: amlodipine besylate breast milk pharmacokinetics chronic hypertension pregnancy
evolution of maternal weight during pregnancy and influence on the endothelial function in her offspring

Conditions: Endothelial Dysfunction; Childhood Obesity

Summary: the rising worldwide prevalence of obesity and its subsequently rising incidence of concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the health care and associated health care costs of future generations. obese pregnant women are a growing population of interest because their offspring is at risk for childhood obesity, an adverse metabolic and inflammatory profile and possible endothelial dysfunction. however, strong evidence is still lacking regarding the hypotheses on the early origin of these long-term health consequences. consequently there is no comprehensive data available on the contribution of changing maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse metabolic and endothelial programming of the offspring. the investigators of this study want to provide additional data on the body composition, metabolic and inflammatory state as well as endothelial function of children of obese pregnant women women and compare the outcome with children born from normal weight women. furthermore, the investigators of this study will stratify the obese pregnant women into 3 groups: women who did not underwent an intervention, women who underwent a weight changing intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent bariatric surgery before pregnancy. the overall aim of the study is to prove that in all the diverse groups of participating children, except the control group, there will be a certain grade of endothelial dysfunction, even if there was a normalization of weight, insulin sensitivity and inflammation before conception or delivery in the mother.


Eligibility criteria:
inclusion criteria: * children of women who previously participated in different cohort studies conducted in flanders concerning maternal obesity are included after contacting the mothers again. during the initial clinical trials the mothers were informed of possible follow-up studies on their offspring. exclusion criteria: * there are no absolute exclusion criteria formulated. * for the peripheral pulse wave amplitude measurement we exclude children on growth hormone therapy. * we postpone the examination for 2 weeks if there is an ongoing infection. * we document the use of specific medication, but the use of it doesn't implicate exclusion of the participating children.

Keywords: maternal obesity endothelial dysfunction childhood obesity
the china valvular heart disease study

Conditions: Valvular Heart Disease

Summary: this is a observational、multicenter, prospective cohort study for adults with significant vhd. the purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with vhd；also to set up registration system of adult vhd in china, to build a database of chinese adult vhd, to establish a web-based international standard data acquisition system for vhd and a multicenter clinical research platform. the results of the study will provide a basis for the future national health policy for prevention and treatment of adult vhd.


Eligibility criteria:
inclusion criteria: * patients over 60 years old meet one of the following conditions. 1. moderate or above valvular heart disease as defined by echocardiography: （1）aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmhg, （2）aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （3）mitral stenosis, moderate or above, or valve area ≤1.5cm2, （4）mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （5）tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, （6）tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, （7）pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec, （8）pulmonic regurgitation, moderate or above, 2. or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation), 3. or diagnosis of endocarditis as assessed by duke criteria. exclusion criteria: * patients cannot be followed up for any reasons. patients have been enrolled in this study.
entre herman@s: promoting health among latino msm

Conditions: HIV Infections

Summary: this is a randomized controlled trial with an attention placebo control group. the goal of this study is to decrease hiv incidence in latino men who have sex with men by engaging their siblings in prep-use promotion. in the intervention arm, siblings will be trained to engage their gay brother in prep conversations. in the control arm, siblings will be trained to engage their gay brother in conversations about vaccines to prevent covid, hepatitis a/b, or mpox.


Eligibility criteria:
inclusion criteria: latino men who have sex with men 1. self-identify as latino 2. identify as male 3. be \<40 years old 4. report hiv-negative status 5. be willing to talk about msm healthcare issues with a sibling 6. either (a) have never used prep or (b) stopped using prep at least 90 days ago 7. missing most recent covid vaccine 8. missing hepatitis (a or b) vaccines 9. missing mpox vaccine 10. meet cdc's prep eligibility criteria (be hiv-negative; any male sex partner in the past six months; not in a monogamous partnership with a recently tested, hiv-negative man; and at least one of the following: any anal sex without condoms in past 6 months, any sexually-transmitted infection (sti) diagnosed or reported in past 6 months, or is in an ongoing sexual relationship with an hiv-positive male partner). exclusion criteria: latino men who have sex with men 1. are unable to provide consent or 2. they do not meet any of the criteria above inclusion criteria: siblings 1. at least 18 years old 2. report a close relationship his/her lmsm brother \<40 years old 3. be willing to talk about msm healthcare issues with his/her lmsm brother exclusion criteria: siblings 1. are unable to provide consent or 2. they do not meet any of the criteria above

Keywords: men who have sex with men latino men hiv prep siblings